WO2001067990A1 - Tige en fil pour stents intravasculaires et stents intravasculaires ainsi conçus - Google Patents

Tige en fil pour stents intravasculaires et stents intravasculaires ainsi conçus Download PDF

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Publication number
WO2001067990A1
WO2001067990A1 PCT/JP2001/001983 JP0101983W WO0167990A1 WO 2001067990 A1 WO2001067990 A1 WO 2001067990A1 JP 0101983 W JP0101983 W JP 0101983W WO 0167990 A1 WO0167990 A1 WO 0167990A1
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WO
WIPO (PCT)
Prior art keywords
vascular stent
monofilament
stent
wire
diameter
Prior art date
Application number
PCT/JP2001/001983
Other languages
English (en)
Japanese (ja)
Inventor
Keiji Igaki
Original Assignee
Keiji Igaki
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Keiji Igaki filed Critical Keiji Igaki
Priority to CA002373961A priority Critical patent/CA2373961C/fr
Priority to US09/979,377 priority patent/US7070615B1/en
Priority to AU41123/01A priority patent/AU780196B2/en
Priority to JP2001566461A priority patent/JP4790960B2/ja
Priority to AT01912330T priority patent/ATE516826T1/de
Priority to EP20010912330 priority patent/EP1184008B9/fr
Publication of WO2001067990A1 publication Critical patent/WO2001067990A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/88—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
    • A61F2/885—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils comprising a coil including a plurality of spiral or helical sections with alternate directions around a central axis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/88—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/91533—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other characterised by the phase between adjacent bands
    • A61F2002/91541—Adjacent bands are arranged out of phase

Definitions

  • the present invention relates to a wire used for a stent to be implanted in a blood vessel such as a coronary artery, and a vascular stent using the wire.
  • a stenosis occurs in a blood vessel such as a coronary artery
  • so-called percutaneous angioplasty PTA
  • percutaneous angioplasty a balloon forming portion attached near the distal end of a catheter is inserted into a stenotic portion of a blood vessel, and is expanded to expand the stenotic portion of the blood vessel to improve blood flow.
  • a percutaneous angioplasty is implanted with a vascular stent to prevent restenosis.
  • Vascular stents retain their shape in the blood vessel for a period of time, preventing restenosis in the site of the till angioplasty.
  • Stent is an extremely useful device not only for acute coronary occlusion, but also for the prevention of distant restenosis and inappropriate percutaneous coronary angioplasty (PTCA), and is widely used in interventional cardiac procedures. Have been. In a comparative clinical experiment using angioplasty with a balloon alone and a stent, it was reported that both the incidence of acute coronary occlusion and the rate of restenosis were lower when the stent was used together.
  • metal stents have a reliable track record in short and medium-term results, but long-term results have been pointed out, for example, for the possibility of unexpected damage to coronary arteries.
  • the main purpose of stent implantation is to avoid acute coronary occlusion and reduce the frequency of restenosis. Since acute coronary occlusion and restenosis are phenomena related to a certain period of time, there are reports that only temporary treatment is required, and the function of the stent is maintained only for the necessary period, and the role has been completed. It is desirable not to remain in the living body as a foreign substance after the treatment. In particular, since the increase in the restenosis rate subsides in about six months, it is necessary to maintain the function of the stent during this period (about six months).
  • Structural structures must have sufficient mechanical properties to enclose blood vessels for a certain period of time.
  • An object of the present invention is to provide a novel vascular stent wire and a vascular stent that satisfy these requirements.
  • a more specific object of the present invention is to provide a vascular stent wire rod and a vascular stent that have bioabsorbability, have excellent antithrombotic properties and physical functions, and can be handled in the same manner as metal stents. It is in.
  • the present inventors have conducted various studies over a long period of time, and as a result, have selected poly (L-lactide), which is a bioabsorbable polymer, as a stent material, and optimized its crystallinity to improve physical function and physical function. It was concluded that bioabsorbability after a certain period of time could be compatible. The present invention has been completed based on such findings.
  • the wire rod for a vascular stent of the present invention is made of poly (L-lactide) which is a bioabsorbable polymer, and has a crystallinity of 15% to 60% as measured by differential scanning calorimetry.
  • the vascular stent of the present invention comprises a wire rod composed of poly (L-lactide) which is a bioabsorbable polymer and having a crystallinity of 15% to 60% as measured by differential scanning calorimetry. It is formed into a cylindrical structure.
  • poly (L-lactide) which is a bioabsorbable polymer and having a crystallinity of 15% to 60% as measured by differential scanning calorimetry. It is formed into a cylindrical structure.
  • the vascular stent formed here is formed with an outer diameter of 2 mm to 5 mm, and is made of a monofilament of 0.08 mm to 0.03 mm thick wire, for example, poly (L-lactide). It is formed.
  • Poly (L-lactide) is a bioabsorbable polymer that, when implanted in a living body, is absorbed into the living body and disappears after a certain period of time.
  • FIG. 1 is a characteristic diagram showing the relationship between the crystallinity of PLL A monofilament and the load at break when immersed in physiological saline at 37 ° C. for 6 months.
  • FIG. 2 is a characteristic diagram showing the relationship between the degree of crystallinity and the load at break during the production of PLLA monofilament.
  • FIG. 3 is a characteristic diagram showing the relationship between the crystallinity of the PLLA monofilament and the elongation at break.
  • FIG. 4 is a schematic diagram showing a process of reducing the diameter of the knitted blood vessel stent.
  • FIG. 5 is a schematic view showing a process of implanting the knitted blood vessel stent into a blood vessel.
  • FIG. 6 is a schematic diagram showing another method of reducing the diameter of a knitted vascular stent.
  • FIG. 7 is a plan view schematically showing an example of a blood vessel stent in which a zigzag PLLA monofilament is formed into a cylindrical shape
  • FIG. 8 is a schematic diagram showing a folded state of the monofilament constituting the stent body.
  • FIG. 9 is an enlarged plan view showing a part of the stent body.
  • FIGS. 10A to 1G are schematic diagrams showing examples of the form of PLL A monofilament in a nonwoven and non-woven state.
  • FIG. 11 is a schematic diagram showing an example of a vascular stent obtained by molding PLA monofilament in a nonwoven and non-woven state into a cylindrical shape.
  • FIG. 12 is a schematic diagram showing another example of a vascular stent in which PLLA monofilament in a nonwoven and non-woven state is formed into a cylindrical shape.
  • the wire rod for a vascular stent according to the present invention is in the form of a thread made of poly (L-lactide), and any form such as monofilament and multifilament can be adopted.
  • monofilament is preferable in consideration of the later-described stent form.
  • the diameter of the monofilament can be set arbitrarily, but is naturally limited by the size of the vascular stent used for the coronary artery, for example.
  • the vascular stent used for the coronary artery has a length of 10 to 50 mm and is formed into a cylindrical structure with a diameter of about 5 mm, which is reduced to a diameter of about 2 mm and inserted into the blood vessel. I am trying to do it.
  • a monofilament having a diameter of 0.3 mm or less As described above, it is necessary to use a monofilament having a diameter of 0.3 mm or less as a monofilament constituting a vascular stent whose diameter is reduced to 2 mm.
  • the monofilament constituting the vascular stent is required to have a certain strength as described later, and a certain elongation rate and a certain elongation are required in order to form a tubular structure while being knitted or bent in a zigzag shape. A certain breaking elongation is also required. From this point of view, the polymer constituting the vascular stent of the size described above is used.
  • the monofilament composed of (L-lactide) must have a diameter of 0.08 mm or more.
  • Poly (L-lactide) (hereinafter referred to as PLLA), which constitutes a wire for a stent, belongs to a biodegradable aliphatic polyester and is a dehydration-condensed polymer of lactic acid in terms of chemical structure. It is a polymer obtained by polymerizing only the L-form lactic acid among the optical isomers.
  • the weight-average molecular weight of this PLLA may be within a range in which it can be processed into a wire, but it is specifically preferably at least 55000.
  • the weight average molecular weight is 55,000 or more, the mechanical properties are saturated, and the strength and elastic modulus do not change even if the weight average molecular weight is increased from this point. Practically, it is 70,000 to 400,000, preferably 100,000 to 300,000. In particular, when a monofilament having a diameter of 0.08 to 0.30 mm as described above is used, it is preferable that the diameter be 100,000 or more.
  • the decomposition rate of the above-mentioned PLLA is determined by the above-mentioned molecular weight, crystallinity, thickness of monofilament, and surface area. Particularly, in the case of crystalline PLLA, Crystallinity and monofilament thickness increase decomposition rate Have an impact.
  • a vascular stent having a tubular structure is formed using PLLLA monofilament, and the stent is implanted in a blood vessel, the strength is reduced due to decomposition.
  • the crystallinity is low, the decomposition rate is high and the strength is greatly reduced. Therefore, there is a lower limit to the degree of crystallinity from the viewpoint of the shape retention period in which the stent with decomposition retains the blood vessel for a predetermined period.
  • the degree of crystallinity from the viewpoint of the shape retention period in which the stent with decomposition retains the blood vessel for a predetermined period.
  • the length is 1 Omn! PL LA for producing a vascular stent with a diameter of about 5 mm as a cylindrical structure with a diameter of about 5 mm, which is inserted into a blood vessel with a diameter of about 2 mm
  • Monofilaments A with a diameter or thickness of 0.3 mm A, B with a thickness of 0.17 mm B, and C with a thickness of 0.08 mm were produced, and these PLLA monofilaments were produced.
  • the crystallinity when immersed in physiological saline at 37 ° C for 6 months and the load at break were confirmed. The results were as shown in Figure 1.
  • the load at break is 6 N or more for tantalum generally used for metal stents.
  • the vascular stent has a length of 10 to 5 Omm and is formed as a cylindrical structure with a diameter of about 5 mm, which is about 2 mm in diameter. And inserted into the blood vessel.
  • the load at break must be 6 N or more. It is. In order to satisfy this condition, as is clear from FIG. 1, even a monofilament A having a thickness of 0.3 mm requires a crystallinity of 25% or more.
  • PLLA monofilament having bioabsorbability is implanted in a living body, and the degree of crystallinity increases with decomposition. That is, the amorphous portion is decomposed first.
  • the PLLA used must have a high degree of physical function.
  • Approaches for structural materials that make up vascular stents include approaches based on elastic modulus and strength (mechanical properties), approaches based on ease of bending and workability (expansion and contraction ability), ease of bending and flexibility (conveyance ability). ).
  • the strength and elastic modulus are one factor of the force for the stent to enclose the blood vessel as a structure, and are preferably equal to or higher than the metal stent. In the case of a metal stent using a tan wire (diameter: 126 m), the strength is about 6 N and the elastic modulus is about 50 GPa.
  • the crystallinity of the PLLA monofilament at the time of preparation must be 15% or more as described above. The higher the crystallinity, the higher the strength. From this viewpoint, it is more advantageous to have the highest crystallinity.
  • bending is required from the viewpoint of expansion / contraction ability and transport ability, and an appropriate degree of breakage is required.
  • a wire considering forming a wire into a steel rod, it must be possible to expand and contract. Also, if the wire is broken during processing, it will not be usable.
  • a cylindrical structure is formed while being knitted in a tubular shape or bent in a zigzag shape. In order to process as such, it is required that the monofilament used as a wire rod can be bent or bent without generating cracks, breakage, or the like during the processing.
  • the PLLA monofilament of 0.08 mm to 0.30 mm that can be used to produce the above-mentioned vascular stent is used.
  • a breaking elongation of 15% or more was required to be able to bend or bend reliably.
  • Figure 3 shows the relationship between the crystallinity and the elongation at break of PLL A monofilaments A, B, and C with thicknesses of 0.30 mm, 0.17 mm, and 0.08 mm, respectively.
  • the elongation at break of each of the monofilaments A, B, and C of each thickness also changes according to the degree of crystallinity, as is evident from Fig. 3.
  • the degree of crystallinity of PLLA monofilament which satisfies the condition of 15.5% or more must be 60% or less when the thickness is 0.08 mm.
  • PLLA monofilament having a crystallinity of 60% or more was hard and brittle, and when folded, easily broken, making it impossible to produce a vascular stent having the size described above.
  • the cross-sectional shape of the monofilament is arbitrary, and examples thereof include a circular shape and an elliptical shape.
  • the decomposition rate is affected by the surface shape and cross-sectional shape of the monofilament, and this decomposition rate is also proportional to the surface area, it is preferable to consider the decomposition rate together with its thickness and crystallinity.
  • Another important item of the material used for vascular stents is antithrombotic properties. Therefore, the antithrombotic properties of the above PLLA will be verified.
  • Platelets obtained by measuring with the column method as an index indicating the antithrombotic properties of the material There is stickiness. High platelet adhesion indicates that the material has low antithrombotic properties and is not suitable for stent materials.
  • microdomain structure In which different properties or substances are alternately arranged.
  • the physical properties of the material differ in micro units, and segmented polyurethane is known as a polymer having structurally antithrombotic properties.
  • the above PLLA has a crystalline / amorphous microdomain structure. Therefore, it is considered that the crystallinity and the antithrombotic property of the PLLA are also closely related.
  • the crystallinity of PLLA used as a wire rod for vascular stent needs to be in the range of 15% to 60% at the time of fabrication.
  • This vascular stent is basically formed by knitting a single thread, that is, knitting, so that the vascular stent is a more uniform vascular stent than a woven fabric formed by crossing so-called warps and wefts. A tubular / tubular body is obtained.
  • this knitted vascular stent is much easier to pass through various meandering blood vessels when transporting the vascular stent to a target site than a metal stent / woven fabric stent. That is, a blood vessel stent made of a knitted material has a trackability with any meandering, and can be implanted in a bent portion. What The reason is that woven tubular and tubular ones have the property that the expanding force is strong and it is difficult to damage the shape of the inner space.
  • the knitted vascular stent is heat-treated to reduce the diameter (heat set) of a tubular or tubular vascular stent knitted to a diameter of about 5 mm in order to insert it into a smaller blood vessel in a living body. The diameter is 2 mm or less, and Fig. 4 shows the process.
  • FIG. 5 shows the concept of implanting the heat-set vascular stent into a blood vessel using a catheter 4 having a balloon 5.
  • FIG. 6 shows another method of reducing the diameter of a vascular stent knitted with PLLLA monofilaments.
  • An advantage of the method shown in FIG. 6 is that a tube made of a heat-resistant resin or metal is not used, so that it can be directly attached to a balloon forming portion near the distal end of the catheter.
  • This vascular stent 1 is a tubular / tubular vascular stent knitted with PLLA thread (PLLA monofilament 2), that is, formed by knitting, and has a different fabric form, that is, a felt-like form. Compared to non-woven fabrics or fabrics using ordinary warp, it has superior flexibility and shape retention. This knitted vascular stent is further heat-treated (heat-set) to achieve its flexibility and shape retention. Has an even more remarkable effect.
  • the tubular / tubular vascular stent 1 knitted with PLLA thread has a diameter of about 4 to 5 mm, and has a diameter of about 1 to 3 mm, preferably 2 mm.
  • the heat set is performed by placing the tube in a tube 3 made of a heat-resistant resin or metal, or by performing heat set while gradually inserting the tube into a tube 3 having a diameter of about 2 mm. (See Figure 4).
  • the knitted tubular / tubular body vascular stent is heat-treated (heat set) at a relatively large diameter state, or the knitted tubular / tubular body is contracted.
  • the knitted fabric that is, the fibers, yarns or stitches at the end of the knitted fabric, has good shapeability, and the heat set has a shape retention property and provides a shape to the inner wall of a living vessel as a vascular stent. It means that the tress can be minimized.
  • the wire for knitting the vascular stent of the present invention must have a change in its cross-sectional shape. However, it is easier than if the vascular stent is made of metal. That is, by making the cross-sectional shape of the filament at the time of spinning into a hollow or irregular shape, a monofilament yarn or a multifilament yarn can be used, and the conformity with the living body and the shape retention can be controlled.
  • the vascular stent of the present invention decomposes and is absorbed by the living body, and a few months later, if the blood vessel restenosis occurs, the vascular stent can be implanted again in the same site. This is because a biodegradable and absorbable polymer is used.
  • a thin sheet of felt-like nonwoven fabric made of a biodegradable absorbent polymer and processed into a tubular or tubular shape has the same level of shape retention and elasticity as the knitted vascular stent of the present invention, It is also possible to use it instead of a knitted structure.
  • a description will be given of a blood vessel stent in which a PLLA monofilament bent in a zigzag shape is formed into a cylindrical shape.
  • the vascular stent 11 is provided with a stent body 13 formed by bending a monofilament 12 made of PLLA having shape memory capability into a zigzag shape and forming the monofilament 12 into a cylindrical shape.
  • the monofilament 12 of PLLA is spirally wound while being bent in a zigzag shape so as to form a continuous V-shape, thereby forming a cylindrical stent body 13.
  • the monofilament 12 is spirally wound by forming one side of one bent portion 14 having a V-shape as a short line portion 14a and the other side as a long line portion 14b.
  • the resulting shape is obtained.
  • the opening angle 01 of the bent portion 14 formed in the middle of the monofilament 12 is almost the same, and the length of the short line portion 14a and the long line portion 14b between the bent portions 14 By making them almost the same, as shown in FIG.
  • the vertices of the bent portions 14 adjacent to each other come into contact with each other. Some or all of the vertices of the bent portions 14 that are in contact with each other are joined together.
  • the monofilaments 12 forming the stent body 13 are reliably maintained in a state of maintaining a cylindrical shape by joining the bent portions 14 at their apexes.
  • bent portions 14 having their vertices in contact with each other are joined by heating, melting, and fusing the joined portions to a melting point Tm or higher.
  • Tm melting point
  • This stent is basically wound around a cylindrical or tubular body without weaving or knitting a single thread, and processed into a tubular or tubular shape. However, even if it is wound along the peripheral surface of a tubular body or a tubular body, it is not a so-called wound state, but as shown in FIGS. 10A to 10G, a monofilament 22.
  • the PLLA monofilament 22 is formed by meandering or forming a ring, and is formed into a curved shape along the peripheral surface so as to embrace the cylindrical body or the tubular body.
  • FIG. 11 shows an example of such a blood vessel stent 21.
  • a meandering PLLA thread is formed in a tubular shape.
  • Fig. 12 shows another example of a vascular stent 21 in which a monofilament of PLLA is a stent in a non-woven and non-woven state, and a loop-shaped PLLA monofilament 22 is similarly formed into a tubular shape. That's what we do.
  • INDUSTRIAL APPLICABILITY As is clear from the above description, according to the present invention, it is possible to provide a vascular stent wire having appropriate bioabsorbability and excellent physical functions. However, by using this, it is possible to provide a vascular stent that exerts its energetic power for a certain period of time and disappears quickly thereafter.

Abstract

Cette invention concerne des tiges en fil destinées à être implantées dans des vaisseaux sanguins, tels que l'artère coronaire, qui comprennent un poly(L-lactide) polymère bio-absorbable et dont le degré de cristallinité, mesuré par calorimétrie à balayage différentiel, se situe entre 15 et 60 %. Les tiges en fil se présentent sous la forme de monofilaments d'un diamètre compris entre 0,08 et 0,30 mm. Ces monofilaments sont moulés et agencés selon une structure cylindrique qui constitue un stent intravasculaire.
PCT/JP2001/001983 2000-03-13 2001-03-13 Tige en fil pour stents intravasculaires et stents intravasculaires ainsi conçus WO2001067990A1 (fr)

Priority Applications (6)

Application Number Priority Date Filing Date Title
CA002373961A CA2373961C (fr) 2000-03-13 2001-03-13 Tige en fil pour stents intravasculaires et stents intravasculaires ainsi concus
US09/979,377 US7070615B1 (en) 2000-03-13 2001-03-13 Linear material for blood vessel stent and blood vessel stent utilizing same
AU41123/01A AU780196B2 (en) 2000-03-13 2001-03-13 Wire rods for vascular stents and vascular stents with the use of the same
JP2001566461A JP4790960B2 (ja) 2000-03-13 2001-03-13 血管ステント用線材及びこれを用いた血管ステント
AT01912330T ATE516826T1 (de) 2000-03-13 2001-03-13 Drahtstangen für gefässprothesen und gefässprothesen unter anwendung derselben
EP20010912330 EP1184008B9 (fr) 2000-03-13 2001-03-13 Tige en fil pour stents intravasculaires et stents intravasculaires ainsi concus

Applications Claiming Priority (2)

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JP2000-73983 2000-03-13
JP2000073983 2000-03-13

Publications (1)

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WO2001067990A1 true WO2001067990A1 (fr) 2001-09-20

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US (1) US7070615B1 (fr)
EP (2) EP1184008B9 (fr)
JP (2) JP4790960B2 (fr)
KR (1) KR100788336B1 (fr)
CN (1) CN1261084C (fr)
AT (1) ATE516826T1 (fr)
AU (1) AU780196B2 (fr)
CA (1) CA2373961C (fr)
DK (1) DK2298366T3 (fr)
ES (2) ES2392798T3 (fr)
PT (1) PT2298366E (fr)
WO (1) WO2001067990A1 (fr)

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JP2013506517A (ja) * 2009-10-06 2013-02-28 アルテリアル・ルモンドラン・テクノロジー・エス・アー 半径方向荷重下で均一に分布した応力を有する生体吸収性血管インプラント
JP2013527778A (ja) * 2010-03-31 2013-07-04 アボット カーディオヴァスキュラー システムズ インコーポレイテッド 分解速度の調節可能なポリ（ｌ−ラクチド）ステントの作製方法
KR20170029081A (ko) 2015-09-04 2017-03-15 연세대학교 산학협력단 의료용 스텐트

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JP2008539002A (ja) * 2005-04-29 2008-11-13 アボット カーディオヴァスキュラー システムズ インコーポレイテッド 非晶質ポリ（ｄ，ｌ−ラクチド）被膜
WO2007119423A1 (fr) * 2006-03-30 2007-10-25 Terumo Kabushiki Kaisha Substance a placer dans le corps vivant
JP5102200B2 (ja) * 2006-03-30 2012-12-19 テルモ株式会社 生体内留置物
JP2007313009A (ja) * 2006-05-25 2007-12-06 Terumo Corp ステント
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JP2013527778A (ja) * 2010-03-31 2013-07-04 アボット カーディオヴァスキュラー システムズ インコーポレイテッド 分解速度の調節可能なポリ（ｌ−ラクチド）ステントの作製方法
KR20170029081A (ko) 2015-09-04 2017-03-15 연세대학교 산학협력단 의료용 스텐트

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DK2298366T3 (da) 2012-11-26
PT2298366E (pt) 2012-11-20
CN1366456A (zh) 2002-08-28
EP1184008B9 (fr) 2012-09-19
JP5059201B2 (ja) 2012-10-24
JP2011092767A (ja) 2011-05-12
EP1184008A4 (fr) 2008-08-06
EP1184008A1 (fr) 2002-03-06
CA2373961C (fr) 2009-06-02
CA2373961A1 (fr) 2001-09-20
KR20020013878A (ko) 2002-02-21
ES2392798T3 (es) 2012-12-13
EP2298366B1 (fr) 2012-08-22
CN1261084C (zh) 2006-06-28
AU780196B2 (en) 2005-03-10
US7070615B1 (en) 2006-07-04
ES2367628T3 (es) 2011-11-07
EP2298366A1 (fr) 2011-03-23
ATE516826T1 (de) 2011-08-15
KR100788336B1 (ko) 2007-12-27
AU4112301A (en) 2001-09-24
JP4790960B2 (ja) 2011-10-12
EP1184008B1 (fr) 2011-07-20

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